510(k) · Cleared
ClearedSPY Elite Intraoperative Perfusion Assessment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novadaq Technologies Ulc. (Now A Part of Stryker) · IZI System, X-Ray, Angiographic
Cleared on Jan 23, 2019 as substantially equivalent to K100371 (Novadaq Technologies, Inc., 2011) and 3 other predicates after a 98-day review. Its family tree reaches back 7 generations to 1994. 14 later devices descend from it.
- Decided
- Jan 23, 2019
- Review
- 98 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K944261 (1994). 22 ancestors in all, the oldest K860913 (1986). 14 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK944261 Retina AngiographHeidelberg Engineering · 1994
- 6 generations backK042961 Spy Intra-Operative Imaging System: SP2000Novadaq Technologies, Inc. · 2005 · Recalled
- 5 generations backK060867 Spy Intraoperative Imaging SystemNovadaq Technologies, Inc. · 2006 · Recalled
- 4 generations backK063345 Spy Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 3 generations backK072222 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2007 · Recalled
- 2 generations backK073088 Spy Fluorescent Imaging SystemNovadaq Technologies, Inc. · 2008
- 1 generation backK100371 Spy Intra-Operative Imaging SystemNovadaq Technologies, Inc. · 2011
- This deviceK182907 SPY Elite Intraoperative Perfusion Assessment SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019
- Descendant · cites it directly · 9 of its ownK192174 SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019
- Descendant · 2 generations on · 8 of its ownK200737 SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020
- Descendant · cites it directly · 5 of its ownK202244 SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020
- Descendant · 2 generations on · 4 of its ownK230727 SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker) · 2023
- Descendant · cites it directly · 2 of its ownK214097 Explorer Air IISurgvision GmbH · 2022
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K192174SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2019 · cites it directly9descendants
- K200737SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020 · 2 generations on8descendants
- K202244SPY-PHI System with SPY-PHI Fluorescence Assessment SoftwareNovadaq Technologies Ulc. (Now A Part of Stryker) · 2020 · cites it directly5descendants
- K230727SPY Portable Handheld Imaging (SPY-PHI) SystemNovadaq Technologies Ulc (A Part of Stryker) · 2023 · 2 generations on4descendants
- K214097Explorer Air IISurgvision GmbH · 2022 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K944261 | Retina Angiograph | Heidelberg Engineering | 1994 | — |
| −6 | K042961 | Spy Intra-Operative Imaging System: SP2000 | Novadaq Technologies, Inc. | 2005 | 1 |
| −5 | K060867 | Spy Intraoperative Imaging System | Novadaq Technologies, Inc. | 2006 | 1 |
| −4 | K063345 | Spy Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −3 | K072222 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2007 | 1 |
| −2 | K073088 | Spy Fluorescent Imaging System | Novadaq Technologies, Inc. | 2008 | — |
| −1 | K100371 | Spy Intra-Operative Imaging System | Novadaq Technologies, Inc. | 2011 | — |
| 0 (this device) | K182907 | SPY Elite Intraoperative Perfusion Assessment System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019 | — |
| +1 | K192174 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2019 | — |
| +2 | K200737 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2020 | — |
| +1 | K202244 | SPY-PHI System with SPY-PHI Fluorescence Assessment Software | Novadaq Technologies Ulc. (Now A Part of Stryker) | 2020 | — |
| +2 | K230727 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc (A Part of Stryker) | 2023 | — |
| +1 | K214097 | Explorer Air II | Surgvision GmbH | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IZI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IZI device
- #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K100371 | Spy Intra-Operative Imaging SystemSummary page 4…232-9841 Email: [email protected] Date 510(k) Summary Prepared: October 12, 2018 Predicate Device(s): SPY System (K100371, K073088, K073130, and K071619) (Novadaq Technologies Inc.) Device Description The SPY Elite System… | 2011 |
| * | K073088 | Spy Fluorescent Imaging SystemSummary page 4…Email: [email protected] Date 510(k) Summary Prepared: October 12, 2018 Predicate Device(s): SPY System (K100371, K073088, K073130, and K071619) (Novadaq Technologies Inc.) Device Description The SPY Elite System is an an… | 2008 |
| * | K073130 | Spy Fluorescent Imaging SystemSummary page 4…Email: [email protected] Date 510(k) Summary Prepared: October 12, 2018 Predicate Device(s): SPY System (K100371, K073088, K073130, and K071619) (Novadaq Technologies Inc.) Device Description The SPY Elite System is an angiographi… | 2008 |
| * | K071619 | Spy Fluorescent Imaging SystemSummary page 4…Email: [email protected] Date 510(k) Summary Prepared: October 12, 2018 Predicate Device(s): SPY System (K100371, K073088, K073130, and K071619) (Novadaq Technologies Inc.) Device Description The SPY Elite System is an angiographic fluorescenc… | 2007 |
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 15 of the 22 ancestors have a recall of any class.
- Of its descendants, K192174 (Novadaq Technologies Ulc. (Now A Part of Stryker), 2019) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K100371.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · IZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
MAUDE reports naming product code IZI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 28 | 6 | 92 |
| 2008 | 6 | 68 | 52 | 101 |
| 2009 | 2 | — | 18 | 132 |
| 2010 | 2 | — | 11 | 252 |
| 2011 | 4 | 104 | 6 | 377 |
| 2012 | 1 | — | 6 | 77 |
| 2013 | 1 | — | 6 | 58 |
| 2014 | 4 | 111 | 5 | 123 |
| 2015 | 0 | — | 14 | 36 |
| 2016 | 1 | — | 7 | 102 |
| 2017 | 2 | — | 1 | 88 |
| 2018 | 2 | — | 2 | 49 |
| 2019 | 2 | — | 2 | 30 |
| 2020 | 1 | — | 2 | 14 |
| 2021 | 1 | — | 1 | 29 |
| 2022 | 1 | — | 0 | 265 |
| 2023 | 3 | 81 | 0 | 1,204 |
| 2024 | 2 | — | 0 | 1,332 |
| 2025 | 2 | — | 0 | 2,171 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Upon intravenous administration of SPY AGENT™ GREEN (Indocyanine green for Injection, USP), the SPY Elite System is used with SPY AGENT™ GREEN to perform intraoperative fluorescence angiography. The SPY Elite System used with SPY AGENT™ GREEN is indicated for use in adult and pediatric patients one month of age and older. The SPY Elite System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after: vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182907 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182907: SPY Elite Intraoperative Perfusion Assessment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182907
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026